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Sponsors and Collaborators: |
National Institute on Aging (NIA) Mead Johnson |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00115024 |
The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD).
Condition | Intervention | Phase |
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Atherosclerosis Postmenopause |
Drug: Micronized 17B-estradiol |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Estrogen in the Prevention of Atherosclerosis Trial |
Estimated Enrollment: | 222 |
Study Start Date: | April 1994 |
Estimated Study Completion Date: | November 1998 |
The primary goal of this randomized, controlled trial is to determine if ERT stabilizes, retards, and/or reverses the progression of atherosclerosis in postmenopausal women. We will further evaluate the association of lipid and non-lipid factors of ERT-mediated reduction in the progression of early atherosclerosis. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery. Blood samples will be used for measuring lipid and non-lipid mediators of ERT.
A total of 222 healthy postmenopausal women 46 to 80 years old without CVD symptoms will be randomized to receive either micronized 17B-estradiol (Estrace) 1mg/day, or a matching placebo tablet daily. All women will be on a low fat/low cholesterol diet, and will receive pravastatin if their LDL cholesterol level exceeds 160 mg/dL. Participants will undergo ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment. Measurements of lipid and non-lipid biochemical markers will also be done at baseline and every 6 months.
Ages Eligible for Study: | 46 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Howard N. Hodis, MD | University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine |
Study ID Numbers: | AG0026, R01AG18798 |
Study First Received: | June 20, 2005 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00115024 |
Health Authority: | United States: Federal Government |
cardiovascular disease CVD estrogen cholesterol |
LDL lipids postmenopausal |
Arterial Occlusive Diseases Atherosclerosis Estradiol 3-benzoate Estradiol valerate Vascular Diseases |
Estradiol 17 beta-cypionate Arteriosclerosis Polyestradiol phosphate Estradiol |
Cardiovascular Diseases |